Steps for PRosTAte Cancer Health and Survival (SPaRTACuS): Pilot Study of a Walking Intervention to Improve Health and Quality of Life in Prostate Cancer Patients - Full Text View

Purpose

The purpose of this study is to determine whether sustainable daily physical activity is effective in improving biological indicators of health and self-reported quality of life in men with prostate cancer.

Condition	Intervention
Prostatic Neoplasm	Behavioral: Walking Intervention Other: Standard of Care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Pilot Intervention Study of the Impact of Sustainable Daily Physical Activity on Health and Quality of Life in a Cohort of Men With Prostate Cancer in Sweden: Steps for PRosTAte Cancer Health and Survival (SPaRTACuS)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Diabetes Medicines Prostate Cancer

U.S. FDA Resources

Further study details as provided by Örebro University, Sweden:

Secondary Outcome Measures:

C-Reactive Protein [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
High-Density Lipoprotein [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Adiponectin [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Total Cholesterol [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Triglycerides [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Insulin [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Testosterone [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Estradiol [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Levels assessed in blood. Blood draw performed by clinician at start and 11 weeks after start of intervention.
Self-Reported Stress [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Self-reported stress level measured using the Perceived Stress Scale-4. Questionnaire completed by participant at start and 11 weeks after start of intervention.
Self-Reported Sleep Quality [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Self-reported sleep quality measured using the Karolinska Sleepiness Scale. Questionnaire completed by participant at start and 11 weeks after start of intervention.
Self-Reported Emotional Quality of Life [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Self-reported emotional quality of life using the 21-Item Depression Anxiety Stress Scale, DASS-21. Questionnaire completed by participant at start and 11 weeks after start of intervention.
Self-Reported Physical Quality of Life [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Self-reported physical quality of life measures related to urinary, bowel, and sexual function using the FACT-P questionnaire. Questionnaire completed by participant at start and 11 weeks after start of intervention.
Blodpressur, systolic and diastolic. [ Time Frame: At time of randomisation(March 1, 2010) and after 11 weeks ] [ Designated as safety issue: No ]
Blodpressur systolic and diastolic, will be assesed by the clinican at randomisation and after 11 weeks

Enrollment:	42
Study Start Date:	March 2010
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Walking Intervention Participants are provided with the current standard of prostate cancer care, and are additionally encouraged to walk 10,000 steps per day, as measured by pedometers provided at start of intervention. Once a week, participants will take part in a group walk with 7-8 other participants and a research nurse. Participants are also encouraged to keep a walking journal, in which they record the number of steps they walk each day. This journal is submitted to investigators at the end of the intervention period.	Behavioral: Walking Intervention Participants are provided with the current standard of prostate cancer care, and are additionally encouraged to walk 10,000 steps per day, as measured by pedometers provided at start of intervention. Once a week, participants will take part in a group walk with 7-8 other participants and a research nurse. Participants are also encouraged to keep a walking journal, in which they record the number of steps they walk each day. This journal is submitted to investigators at the end of the intervention period.
Active Comparator: Standard of Care Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.	Other: Standard of Care Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.

Arms

Assigned Interventions

Experimental: Walking Intervention

Participants are provided with the current standard of prostate cancer care, and are additionally encouraged to walk 10,000 steps per day, as measured by pedometers provided at start of intervention. Once a week, participants will take part in a group walk with 7-8 other participants and a research nurse. Participants are also encouraged to keep a walking journal, in which they record the number of steps they walk each day. This journal is submitted to investigators at the end of the intervention period.

Behavioral: Walking Intervention

Participants are provided with the current standard of prostate cancer care, and are additionally encouraged to walk 10,000 steps per day, as measured by pedometers provided at start of intervention. Once a week, participants will take part in a group walk with 7-8 other participants and a research nurse. Participants are also encouraged to keep a walking journal, in which they record the number of steps they walk each day. This journal is submitted to investigators at the end of the intervention period.

Active Comparator: Standard of Care

Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.

Other: Standard of Care

Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.

Detailed Description:

Living with prostate cancer is a unique challenge faced by millions of men across the globe. Existing research has indicated many potential methods of attenuating prostate cancer progression and preserving patients' quality of life, but is lacking in definitive conclusions regarding the effectiveness of these methods in practice. This study seeks to further investigate the impact of post-diagnosis physical activity on biological indicators of health and self-reported quality of life in a cohort of men with prostate cancer in Sweden. Participants are randomized to either a walking intervention group, which encourages walking 10,000 steps per day for one year, or to a standard-or-care control group, and followed for 11 weeks.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 80 years or younger
Histologic confirmation of prostate cancer
Clinically or pathologically staged as locally advanced or early metastatic prostate cancer
Diagnosis within 1 year of study enrollment
Willing and able to walk 10,000 steps per day

Exclusion Criteria:

Age greater than 80 years old at enrollment
Inability to understand the language spoken in host country
Physically unable to walk 100 meters unassisted
Diagnosed with dementia or severe psychiatric disease
Any prior cancer diagnosis
Has experienced a myocardial infarction or stroke within six months of cancer diagnosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696539

Locations

Sweden
Orebro University
Orebro, Narke, Sweden, 701-82

Sponsors and Collaborators

Örebro University, Sweden

Harvard School of Public Health

Investigators

Principal Investigator:

Ove Andren, PhD

Orebro University

More Information

Additional Information:

Orebro University English Homepage This link exits the ClinicalTrials.gov site

Harvard School of Public Health Homepage This link exits the ClinicalTrials.gov site

Publications:

Kenfield SA, Stampfer MJ, Giovannucci E, Chan JM. Physical activity and survival after prostate cancer diagnosis in the health professionals follow-up study. J Clin Oncol. 2011 Feb 20;29(6):726-32. Epub 2011 Jan 4.

Flanagan J, Gray PK, Hahn N, Hayes J, Myers LJ, Carney-Doebbeling C, Sweeney CJ. Presence of the metabolic syndrome is associated with shorter time to castration-resistant prostate cancer. Ann Oncol. 2011 Apr;22(4):801-7. Epub 2010 Sep 29.

Edwards LA, Woo J, Huxham LA, Verreault M, Dragowska WH, Chiu G, Rajput A, Kyle AH, Kalra J, Yapp D, Yan H, Minchinton AI, Huntsman D, Daynard T, Waterhouse DN, Thiessen B, Dedhar S, Bally MB. Suppression of VEGF secretion and changes in glioblastoma multiforme microenvironment by inhibition of integrin-linked kinase (ILK). Mol Cancer Ther. 2008 Jan;7(1):59-70.

Giovannucci E, Rimm EB, Liu Y, Leitzmann M, Wu K, Stampfer MJ, Willett WC. Body mass index and risk of prostate cancer in U.S. health professionals. J Natl Cancer Inst. 2003 Aug 20;95(16):1240-4.

Platz EA, Leitzmann MF, Visvanathan K, Rimm EB, Stampfer MJ, Willett WC, Giovannucci E. Statin drugs and risk of advanced prostate cancer. J Natl Cancer Inst. 2006 Dec 20;98(24):1819-25.

Li H, Stampfer MJ, Mucci L, Rifai N, Qiu W, Kurth T, Ma J. A 25-year prospective study of plasma adiponectin and leptin concentrations and prostate cancer risk and survival. Clin Chem. 2010 Jan;56(1):34-43. Epub 2009 Nov 12.

Irwin ML, Duggan C, Wang CY, Smith AW, McTiernan A, Baumgartner RN, Baumgartner KB, Bernstein L, Ballard-Barbash R. Fasting C-peptide levels and death resulting from all causes and breast cancer: the health, eating, activity, and lifestyle study. J Clin Oncol. 2011 Jan 1;29(1):47-53. Epub 2010 Nov 29.

Keogh JW, MacLeod RD. Body composition, physical fitness, functional performance, quality of life, and fatigue benefits of exercise for prostate cancer patients: a systematic review. J Pain Symptom Manage. 2012 Jan;43(1):96-110. doi: 10.1016/j.jpainsymman.2011.03.006. Epub 2011 Jun 2. Review.

Tudor-Locke C, Craig CL, Brown WJ, Clemes SA, De Cocker K, Giles-Corti B, Hatano Y, Inoue S, Matsudo SM, Mutrie N, Oppert JM, Rowe DA, Schmidt MD, Schofield GM, Spence JC, Teixeira PJ, Tully MA, Blair SN. How many steps/day are enough? For adults. Int J Behav Nutr Phys Act. 2011 Jul 28;8:79. Review.

Responsible Party:	Ove Andrén, Associate Professor and Chair of Urology, Örebro University, Sweden
ClinicalTrials.gov Identifier:	NCT01696539 History of Changes
Other Study ID Numbers:	Spartacus01
Study First Received:	September 16, 2012
Last Updated:	September 27, 2012
Health Authority:	Sweden: Institutional Review Board

Keywords provided by Örebro University, Sweden:

Prostate Cancer

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms

Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013